Postoperative DeliriumNCT05456230
Comparison of Postoperative Delirium in Elders Anaesthetised With Midazolam and Without Midazolam
An observational study of Postoperative Delirium, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This research project is an observational cohort study by prospective chart review of patients that underwent surgery in multi-centers, China, in the years 2020-2022. The purpose of this study is to compare the occurrence of postoperative delirium With Midazolam and Without Midazolam During Non-cardiac Surgery in… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Midazolam
- How many people
- 11,927 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 11 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Older adult
Study population: hospital based group
Who may be able to join
- Geriatric surgical patients ≥65 years old Underwent elective non-cardiac surgery
Who cannot join
- History of neuropsychiatric diseases including delirium, mental disorders, Parkinson, dementia, etc.; The operation was cancelled due to various reasons after the patient was enrolled; severe liver disease; severe renal dysfunction defined as either having creatinine clearance < 30 ml/min or being dialysis-dependent; Patients who undergo second operation in a short period; Refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postoperative Delirium in Elders Anaesthetised With Midazolam and Without Midazolam During Non-cardiac Surgery
This research project is an observational cohort study by prospective chart review of patients that underwent surgery in multi-centers, China, in the years 2020-2022. The purpose of this study is to compare the occurrence of postoperative delirium With Midazolam and Without Midazolam During Non-cardiac Surgery in Elders.
Read the detailed description
Post operative delirium will be diagnosed using the 3D- CAM(Confusion Assessment Method) which tests for four features with a series of questions. The features include 1) acute onset and fluctuating course,2) inattention,3) disorganized thinking and 4) altered level of consciousness. Diagnosis of delirium is made if features 1 and 2 and either 3 or 4 are present.
The demographic data of the patients,type and site of surgery will be noted. Preoperative hemoglobin, serum electrolytes and blood urea will be recorded. The intraoperative factors like duration of surgery and anaesthesia,use of intravenous fluids ,blood loss, number blood units transfused and opioid use will be studied at the time of surgery. The time to emergence and extubation following the completion of surgery will be noted.
The postoperative factors like postoperative pain, nausea and vomiting, fever,hemoglobin,serum electrolytes and blood urea will be noted.
Preoperative and postoperative pain will be assessed using the numerical rating score on a scale of one to ten.
The association of various preoperative,intraoperative and postoperative factors with POD will be determined.
- Conditions
- Postoperative Delirium
- Being tested
- Midazolam
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called benzodiazepines
Midazolam as a premedication was given as the patient is taken to the operating room and typically within 15 minutes of anesthetic induction.
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Midazolam as a premedication was given as the patient is taken to the operating room and typically within 15 minutes of anesthetic induction. Receives: Drug: Midazolam | |
| Non-Midazolam | Midazolam was not given during the operation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
Measured: Day 1 postoperatively
Incidence of postoperative delirium
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
Measured: Day 2 postoperatively
Incidence of postoperative delirium
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
Measured: Day 3 postoperatively
Incidence of postoperative delirium
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
Measured: Day 4 postoperatively
Incidence of postoperative delirium
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
Measured: Day 5 postoperatively
Incidence of postoperative delirium
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
Measured: Day 7 postoperatively
Secondary outcomes (1)
the incidence of survival rate
collection of clinical data in the medical record and follow-up update
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Apr 2020
- Primary completion30 Apr 2022
- Study completion11 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11,927 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Peking University First Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Xiangya Hospital of Central South University, Beijing Anzhen Hospital, China-Japan Friendship Hospital, Fudan University, Central South University, Peking University People's Hospital, Zhejiang University, Sun Yat-sen University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Taihe Hospital, The Affiliated Hospital Of Guizhou Medical University, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital of Guangxi Medical University, Zhejiang Provincial People's Hospital
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
- Investigators
- Weidong Mi, PhD, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456230
- Sponsor's protocol ID
- PLAGH-POD-001
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Delirium in Elders Anaesthetised With Midazolam and Without Midazolam During Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT05456230
- Acronym / sponsor ID
- PLAGH-POD-001
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,927 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Peking University First Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Xiangya Hospital of Central South University, Beijing Anzhen Hospital, China-Japan Friendship Hospital, Fudan University, Central South University, Peking University People's Hospital, Zhejiang University, Sun Yat-sen University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Taihe Hospital, The Affiliated Hospital Of Guizhou Medical University, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital of Guangxi Medical University, Zhejiang Provincial People's Hospital
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 11 Jul 2022 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research project is an observational cohort study by prospective chart review of patients that underwent surgery in multi-centers, China, in the years 2020-2022. The purpose of this study is to compare the occurrence of postoperative delirium With Midazolam and Without Midazolam During Non-cardiac Surgery in Elders.
Detailed description
Post operative delirium will be diagnosed using the 3D- CAM(Confusion Assessment Method) which tests for four features with a series of questions. The features include 1) acute onset and fluctuating course,2) inattention,3) disorganized thinking and 4) altered level of consciousness. Diagnosis of delirium is made if features 1 and 2 and either 3 or 4 are present.
The demographic data of the patients,type and site of surgery will be noted. Preoperative hemoglobin, serum electrolytes and blood urea will be recorded. The intraoperative factors like duration of surgery and anaesthesia,use of intravenous fluids ,blood loss, number blood units transfused and opioid use will be studied at the time of surgery. The time to emergence and extubation following the completion of surgery will be noted.
The postoperative factors like postoperative pain, nausea and vomiting, fever,hemoglobin,serum electrolytes and blood urea will be noted.
Preoperative and postoperative pain will be assessed using the numerical rating score on a scale of one to ten.
The association of various preoperative,intraoperative and postoperative factors with POD will be determined.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam | – | Drug: MidazolamMidazolam as a premedication was given as the patient is taken to the operating room and typically within 15 minutes of anesthetic induction. |
| Non-Midazolam | – | –Midazolam was not given during the operation. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- hospital based group
Key inclusion criteria (1 listed)
- Geriatric surgical patients ≥65 years old Underwent elective non-cardiac surgery
Key exclusion criteria (1 listed)
- History of neuropsychiatric diseases including delirium, mental disorders, Parkinson, dementia, etc.; The operation was cancelled due to various reasons after the patient was enrolled; severe liver disease; severe renal dysfunction defined as either having creatinine clearance < 30 ml/min or being dialysis-dependent; Patients who undergo second operation in a short period; Refused to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamAlso: benzodiazepinesMidazolam as a premedication was given as the patient is taken to the operating room and typically within 15 minutes of anesthetic induction. | Drug | Midazolam |
Primary outcome
Incidence of postoperative delirium
Time frame: Day 1 postoperatively
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
Incidence of postoperative delirium
Time frame: Day 2 postoperatively
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
Incidence of postoperative delirium
Time frame: Day 3 postoperatively
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
Incidence of postoperative delirium
Time frame: Day 4 postoperatively
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
Incidence of postoperative delirium
Time frame: Day 5 postoperatively
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
Incidence of postoperative delirium
Time frame: Day 7 postoperatively
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
1 secondary outcome
the incidence of survival rate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Individual participant dataSharing planned: No
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The Danish Out-of-Hospital Cardiac Arrest Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weidong Mi, PhD study chair
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: Day 1 postoperatively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.